BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI CHAIR

    MDR report key: 8355195 · Received February 20, 2019

    Report

    Report Number
    3009481053-2019-00008
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 21, 2019
    Report Date
    February 20, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    1ST INCIDENT: CNA WAS MOVING INDIVIDUAL INTO SHOWER WHEN WHEEL FELL OFF. INDIVIDUAL WAS NOT HURT AND WAS ABLE TO WALK TO ANOTHER CHAIR. 2CD INCIDENT: CNA WAS IN THE SHOWER ROOM WITH PATIENT. CNA WAS HOLDING ON TO COMBI CHAIR WHEN THE WHEEL FELL OFF. THE CNA AND WAS ABLE TO STEADY THE CHAIR SO THAT THE PATIENT DID NOT FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147308 COMBI CHAIR CHAIR WITH CASTERS INM HANDICARE AB 201904314

    Patients

    Seq Age Sex Outcome Treatment
    1